Cryolife Inc CryoValve, Aortic Valve & Conduit SG Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
CryoValve, Aortic Valve & Conduit SG
Brand
Cryolife Inc
Lot Codes / Batch Numbers
Donor #63601, Serial #7846205, Model #SGAV00
Products Sold
Donor #63601, Serial #7846205, Model #SGAV00
Cryolife Inc is recalling CryoValve, Aortic Valve & Conduit SG due to During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' ti. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
During a retrospective review, CryoLife noted that the donor tissue exceeded the acceptable warm ischemic time when utilizing the 'Last Seen Alive' time in their calculation.
Recommended Action
Per FDA guidance
Consignees were notified by letters dated 12/17/2004, 01/03/2005 and 01/19/2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, NJ, TX
Page updated: Jan 10, 2026